Heart FailureNCT03659877
Identifying Physical Activity Intensity Through Accelerometry in Heart Failure
A study testing Physical activity in people with Heart Failure, run by University of Exeter at 1 site in United Kingdom.
Trial summary
The primary objective of this study is to identify and evaluate the range of values provided by accelerometers during a variety of typical daily lifestyle activities for heart failure patients, and to relate these to the measured intensity of performing each activity in the heart failure population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2018to 23 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient willing and able to give written informed consent to participate in study
- Adult (aged ≥18 years)
- Patients with confirmed diagnosis of heart failure
- Stable symptoms of heart failure
Who cannot join
- Patients with contraindications to exercise testing or physical activity
- Patients who are in a long term care establishment or who are unwilling or unable to travel to research site
- Patients who are unable to understand the study information.
- Patients judged to be unable to participate in the study for any other reason (e.g. diagnosis of dementia, psychiatric disorder, life-threatening comorbidity).
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to identify and evaluate the range of values provided by accelerometers during a variety of typical daily lifestyle activities for heart failure patients, and to relate these to the measured intensity of performing each activity in the heart failure population.
Read the detailed description
The precise measurement of physical activity is now possible with advances in wearable technology, namely accelerometers. This is useful in order to properly evaluate interventions such as cardiac rehabilitation that aim to increase physical activity. One of the challenges with accelerometry is the need for raw data to be translated into meaningful behavioural units. This is addressed through a calibration study, where accelerometry data is related to oxygen consumption and cut points are derived where activity is considered light, moderate or vigorous intensity. However, calibration studies have only been done in young and healthy adults, not in the elderly or those with chronic disease such as heart failure where movements are slower and exercise capacity is reduced. This means there is a risk of underestimating the true level of physical activity in this population. Therefore the aim of this study is to run a calibration study with 18-30 heart failure patients.
Adults (aged 18 years and older) diagnosed with heart failure, with stable symptoms that are willing and able to give informed consent will be eligible for the study. Patients with contraindications to physical activity will be excluded from the study. Patients will be identified from the Royal Devon \& Exeter NHS Foundation Trust and the study will be conducted in the sports science laboratory at St Luke's Campus, University of Exeter. Each patient will be required to attend a single study visit that should last approximately 3 hours in total. During the visit patients will be required to complete a number of physical activity tasks (such as lying, sitting and walking) whilst wearing various accelerometers and gas analysis equipment.
- Conditions
- Heart Failure
- Being tested
- Physical activity
- Keywords
- Physical Activity, Accelerometer
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Participants will undertake a variety of typical daily physical activities, such as laying down, sitting, walking whilst wearing accelerometers and gas analysis equipment.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients | Experimental | Patients will be required to perform a number of physical activity tasks such as laying down, sitting and walking. During these activities, acceleration, oxygen consumption, rating of perceived exertion and heart rate will be recorded. Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceleration
acceleration (milli-g) values obtained via GENEActiv accelerometer (Activinsights, Kimbolton, UK) at multiple wear locations (both wrists, left thigh). Acceleration measured at 100Hz. Raw data reduced to one second epochs, then the average of these 1 second epochs calculated for each activity the patient completes.
Measured: Accelerometers worn for up to three hours throughout the single patient visit. Accelerometers fitted after patient signs informed consent and worn until completion of the protocol (up to 3 hours).
Secondary outcomes (5)
Oxygen consumption (VO2)
Breath-by-breath gas analysis. The average during the last minute of each activity the patient completes as per protocol is used.
Measured: Gas analysis equipement is fitted after patient signs informed consent and worn until completion of the study protocol, up to three hours in one single patient visit.
Carbon dioxide production (VCO2)
Breath-by-breath gas analysis. The average during the last minute of each activity the patient completes as per protocol is used.
Measured: Gas analysis equipement is fitted after patient signs informed consent and worn until completion of the study protocol, up to three hours in one single patient visit.
Respiratory Exchange Ratio (RER)
Breath-by-breath gas analysis. The average during the last minute of each activity the patient completes as per protocol is used.
Measured: Gas analysis equipement is fitted after patient signs informed consent and worn until completion of the study protocol, up to three hours in one single patient visit.
Rating of Perceived Exertion (RPE)
Borg Rating of Perceived Exertion scale (minimum score 6- maximum score 20). This is a subjective measure of how hard the patient feels they are exerting themselves.
Measured: This is collected throughout study completion (up to 3 hours). The patient is asked to give their RPE score during the last minute of each activity
Heart Rate
Heart rate measured via pulse oximeter
Measured: Measured throughout study completion (up to three hours). It is collected during the last minute of each activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start3 Apr 2018
- Primary completion23 Oct 2018
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace Dibben, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659877
- Sponsor's protocol ID
- 1617/036
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2017
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dibben GO, Gandhi MM, Taylor RS, Dalal HM, Metcalf B, Doherty P, Tang LH, Kelson M, Hillsdon M. Physical activity assessment by accelerometry in people with heart failure. BMC Sports Sci Med Rehabil. 2020 Aug 12;12:47. doi: 10.1186/s13102-020-00196-7. eCollection 2020.
PubMed 32817798
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Physical Activity Intensity Through Accelerometry in Heart Failure
- ClinicalTrials.gov ID
- NCT03659877
- Acronym / sponsor ID
- 1617/036
- Conditions
- Heart Failure
- Keywords
- Physical Activity, Accelerometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to identify and evaluate the range of values provided by accelerometers during a variety of typical daily lifestyle activities for heart failure patients, and to relate these to the measured intensity of performing each activity in the heart failure population.
Detailed description
The precise measurement of physical activity is now possible with advances in wearable technology, namely accelerometers. This is useful in order to properly evaluate interventions such as cardiac rehabilitation that aim to increase physical activity. One of the challenges with accelerometry is the need for raw data to be translated into meaningful behavioural units. This is addressed through a calibration study, where accelerometry data is related to oxygen consumption and cut points are derived where activity is considered light, moderate or vigorous intensity. However, calibration studies have only been done in young and healthy adults, not in the elderly or those with chronic disease such as heart failure where movements are slower and exercise capacity is reduced. This means there is a risk of underestimating the true level of physical activity in this population. Therefore the aim of this study is to run a calibration study with 18-30 heart failure patients.
Adults (aged 18 years and older) diagnosed with heart failure, with stable symptoms that are willing and able to give informed consent will be eligible for the study. Patients with contraindications to physical activity will be excluded from the study. Patients will be identified from the Royal Devon \& Exeter NHS Foundation Trust and the study will be conducted in the sports science laboratory at St Luke's Campus, University of Exeter. Each patient will be required to attend a single study visit that should last approximately 3 hours in total. During the visit patients will be required to complete a number of physical activity tasks (such as lying, sitting and walking) whilst wearing various accelerometers and gas analysis equipment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients | Experimental | Behavioral: Physical activityPatients will be required to perform a number of physical activity tasks such as laying down, sitting and walking. During these activities, acceleration, oxygen consumption, rating of perceived exertion and heart rate will be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient willing and able to give written informed consent to participate in study
- Adult (aged ≥18 years)
- Patients with confirmed diagnosis of heart failure
- Stable symptoms of heart failure
Key exclusion criteria (4 listed)
- Patients with contraindications to exercise testing or physical activity
- Patients who are in a long term care establishment or who are unwilling or unable to travel to research site
- Patients who are unable to understand the study information.
- Patients judged to be unable to participate in the study for any other reason (e.g. diagnosis of dementia, psychiatric disorder, life-threatening comorbidity).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityParticipants will undertake a variety of typical daily physical activities, such as laying down, sitting, walking whilst wearing accelerometers and gas analysis equipment. | Behavioural | Heart failure patients |
Primary outcome
Acceleration
Time frame: Accelerometers worn for up to three hours throughout the single patient visit. Accelerometers fitted after patient signs informed consent and worn until completion of the protocol (up to 3 hours).
acceleration (milli-g) values obtained via GENEActiv accelerometer (Activinsights, Kimbolton, UK) at multiple wear locations (both wrists, left thigh). Acceleration measured at 100Hz. Raw data reduced to one second epochs, then the average of these 1 second epochs calculated for each activity the patient completes.
5 secondary outcomes
Oxygen consumption (VO2)
Time frame: Gas analysis equipement is fitted after patient signs informed consent and worn until completion of the study protocol, up to three hours in one single patient visit.
Carbon dioxide production (VCO2)
Time frame: Gas analysis equipement is fitted after patient signs informed consent and worn until completion of the study protocol, up to three hours in one single patient visit.
Respiratory Exchange Ratio (RER)
Time frame: Gas analysis equipement is fitted after patient signs informed consent and worn until completion of the study protocol, up to three hours in one single patient visit.
Rating of Perceived Exertion (RPE)
Time frame: This is collected throughout study completion (up to 3 hours). The patient is asked to give their RPE score during the last minute of each activity
Heart Rate
Time frame: Measured throughout study completion (up to three hours). It is collected during the last minute of each activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Derived from this study: PubMed 32817798Dibben GO, Gandhi MM, Taylor RS, Dalal HM, Metcalf B, Doherty P, Tang LH, Kelson M, Hillsdon M. Physical activity assessment by accelerometry in people with heart failure. BMC Sports Sci Med Rehabil. 2020 Aug 12;12:47. doi: 10.1186/s13102-020-00196-7. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Dibben principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Heart Failure, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceleration (time frame: Accelerometers worn for up to three hours throughout the single patient visit. Accelerometers fitted after patient signs informed consent and worn until completion of the protocol (up to 3 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03659877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.